FDA approves clinical fMRI tool

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Neurognostics Inc. of Milwaukee, Wis. has received U.S. FDA 510(k) approval to market its MindState functional Data Acquisition Device (fDAD).
   
According to Neurognostics, fDAD enables healthcare professionals to acquire fMRI data that may be used to track disease progression in patients afflicted by disorders of the central nervous system (CNS) and to test drug efficacy.
   
The technology operates in conjunction with a 1.5 or 3 Tesla MRI scanner. The device works by presenting patients with cognitive or motor stimuli while collecting time-synchronized patient responses and MR images. These data are archived and can later be processed and used to provide information to the physicians regarding the outcome or assessment of interest.
   
"fDAD is only the first step to performing clinical fMRI," says Douglas Tucker, PhD, CEO of Neurognostics. "Performing clinical fMRI requires the use of specific paradigms, data acquisition protocols, and data processing algorithms. Neurognostics' goal is to provide physicians with a suite of tools that address all aspects of clinical fMRI."  
   
In October 2004, Neurognostics received a Phase I Small Business Innovative Research Grant from the National Institutes of Health (NIH). The grant supports the development of fMRI-based biomarkers, including the processing and reporting algorithms applied to drug efficacy testing in Parkinson's disease. Neurognostics said it plans to develop applications for a variety of neurodegenerative and neurodevelopmental disorders including Attention Deficit Hyperactivity Disorder (ADHD), Alzheimer's and Multiple Sclerosis.